Status:
COMPLETED
An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.
Eligibility Criteria
Inclusion
- Key Inclusion criteria:
- Age 18 years and above.
- Diagnosed with urinary urgency-frequency syndrome.
- Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.
- Have normal upper urinary tract function.
- Be capable of giving informed consent.
- Be capable and willing to follow all study related procedures.
- Key Exclusion Criteria:
- Have any active implantable device regardless of whether stimulation status is ON or OFF.
- Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 month period.
- Less than one year post partum and/or are breast-feeding.
- Have any large passive implant that contains metal located within 30 cm of the chair pad while seated (e.g., hip replacement).
- Have conditions requiring magnetic resonance imaging (MRI) evaluation.
- Have conditions requiring diathermy procedures.
- Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
- Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
- Have history of coagulopathy or bleeding disorder.
- Have pelvic pain in the absence of voiding dysfunction.
- Have anatomical restrictions such that the study device placement is not possible.
- Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
- Cannot independently comprehend and complete the questionnaires.
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00131573
Start Date
May 1 2004
End Date
December 1 2012
Last Update
November 19 2013
Active Locations (11)
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1
Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5077
2
The Department of Urology, Stanford University Medical Center
Stanford, California, United States, 94305-5118
3
Milestone Medical Research
Englewood, Colorado, United States, 80112
4
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307-5001